The safety and effectiveness of donanemab—an Alzheimer's drug recently approved by the US Food & Drug Administration (FDA)—is called into question in an investigation published by The BMJ . Journalists Jeanne Lenzer and Shannon Brownlee explore concerns not only about its effectiveness and the number of deaths among patients taking the drug, but also about financial ties to drug makers among the "independent" advisory panelists who recommended approval. Donanemab, developed by Eli Lilly, is the latest in a new class of anti-amyloid drugs that deliver antibodies to target beta amyloid, a protein believed to cause Alzheimer's disease.
In January 2023, the FDA denied approval of donanemab, citing a "high rate" of missing data and questioning the drug's long term safety. The agency noted a higher rate of treatment discontinuation due to adverse events (frequently brain hemorrhage and swelling) among patients on donanemab compared with placebo, and an "imbalance" in overall deaths. Lilly acknowledged three deaths in patients on donanemab, and an outside company it hired to obtain the missing data found two additional deaths among patients in the donanemab arm and five deaths in the placebo arm.
But Steven Goodman, an expert in clinical trial design at Stanford University, says it is not possible to assess the reliability of the new data without more details of the outside company's methods. "There was also no information on health outcomes in those patients other than death , .